Principal Scientist, Aseptic Control - MSAT Process
Core
Principal Scientist leading aseptic control strategies for sterile and low bioburden processing of cell and gene therapy, small molecule, and combination medical device programs.
Role type
Principal Scientist, Aseptic Control
Builds
Sterile drug substance and drug product manufacturing processes for biologics and cell therapies
Domain
Biopharmaceuticals / Cell and Gene Therapy / Aseptic Processing
Required skills
Aseptic processing technologies, Microbial testing strategies, Filter integrity, Clean room facility monitoring, Risk-based approaches, Root cause analysis, Deviation management, GMP regulations
Preferred skills
Microbiology, Sterile dosage form design, CDMO collaboration, Industry consortia participation
Technologies
GMP facilities, Aseptic filling equipment, Environmental monitoring systems
Responsibilities
Define strategies for microbial control of gowning and facility monitoring programs, Provide technical input into contamination events and design corrective actions, Support regulatory submissions and pre-approval inspections, Design aseptic filling processes for novel device platforms, Establish post-approval performance monitoring capabilities
Seniority
Principal, technical leadership & strategy
